MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP ANT 1ST LEDGE SZ2.5-3; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	950502093
Medical Device Problem Codes	Break (1069); Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the instrument was worn- screw broken in 950502093 2.5-3 sigma hp modular anterior first cut guide for 4n1 block.Sigma art trial rp ps sz 2 x 12.5mm plastic worn on bottom and will not fit over mbt keel or blue bullet.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.The investigation findings did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The ledge was not broken.The captured screw within the ledge broke.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: concomitant medical products, device manufacture date, event.Corrected: device evaluated by mfr.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP ANT 1ST LEDGE SZ2.5-3
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9131160
• Report Number: 1818910-2019-106671
• Device Sequence Number: 3008115
• Product Code: LXH
• UDI-Device Identifier: 10603295227953
• UDI-Public: 10603295227953
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 950502093
• Device Lot Number: A1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019; 09/06/2019; 10/18/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 09/27/2019; 10/04/2019; 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1